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Regenerative Tissue Matrix
Complex acellular heterogenous scaffold and blood vessel architecture

Biology of repair: Regeneration is key

Harnessing the body’s natural processes is essential to restoring and maintaining the structure, function, and physiology of tissue. Upon tissue injury, the body will begin the repair or regeneration process, based on its recognition of the material used. An intact, extracellular tissue matrix contains the ideal scaffold with critical cellular and biochemical components to support the regenerative process.1,2

As shown in preclinical studies, a scaffold is recognized either positively or negatively†



†Correlation of these results, based on animal studies, to results in humans has not been established.

Demonstrated inflammation

At 1 month, a robust foreign body response was observed with resorbable synthetics in preclinical studies

As shown below, the black arrows indicate macrophages as well as foreign-body giant cell predominated inflammatory response and encapsulation of the synthetic fiber bundles.4-7

Primary response: Inflammation and macrophage proliferation

Short-term resorbable5

Long-term resorbable6

Permanent7

All samples are from 1-month implantation in nonhuman primate-abdominal wall repair (NHP-AWR) models from 3 different studies. These studies followed the same protocol and were performed at the same institution at different times. Hematoxylin & Eosin (H&E) stains collagen fibers pink and cell nuclei blue-purple. Nuclei of lymphocytes are round, fibroblasts are elongated, and macrophages are round and diffuse. Each image is shown stained with H&E at 200x magnification.

Demonstrated scar formation

Evidence of robust scar formation was observed around the synthetic fibers in preclinical studies

Alpha-smooth muscle actin (α-SMA)–positive capsule forms around the synthetic fibers as part of the foreign-body response, which is stained brown in the examples below. This indicates the formation of scar tissue, which may be weak and contractile. 4-8

Secondary phase: Deposition of fibrotic scar in a primate model

Short-term resorbable5

1 month

Long-term resorbable6

6 months

Permanent7

6 months

All samples are from implantation in NHP-AWR models from 3 different studies. These studies followed the same protocol and were performed at the same institution at different times. The PGA-TMC sample is shown at 1 month because it is fully resorbed by 6 months (unlike the other 2 samples). Myofibroblasts produce α-smooth muscle α-SMA, which is a contractile protein often found in scar tissue that stains brown with α-SMA staining. Each image is shown at 200x magnification.

Demonstrated encapsulation

Fibrotic capsule formed around the fibers of resorbable synthetics in preclinical studies

Capsule formation around the synthetic fibers was demonstrated in scanning electron microscopy images, which may contribute to mesh contraction in vivo. White arrows depict a denser and more pronounced capsule at 6 months for P4HB mesh.5-7

Secondary phase: Encapsulation in a primate model

Short-term resorbable5

1 month

Long-term resorbable6

1 month

Long-term resorbable6

6 months

All samples are from implantation in NHP-AWR models from 3 different studies. These studies followed the same protocol and were performed at the same institution at different times. The PGA-TMC sample is shown at 1 month only because it is fully resorbed by 6 months. To best capture capsule formation around individual polymer mesh fibers with varying diameters, the PGA-TMC sample is shown at 500x magnification, while the P4HB samples are shown at 100x (1 month) and 200x (6 months).

Demonstrated resorption

Loss of domain and contraction were observed with the synthetic meshes in preclinical studies

The resorbable synthetics elicited a contractile response at 1 month similar to polypropylene synthetic mesh, without the benefits of reinforcement past their resorption profiles.4-7,9

Resorption

Loss of domain

Contraction

16.0% ± 4.9%
contraction

58.3% ± 10.2%
contraction

36.7% ± 17.3%
contraction

9.4% ± 14.3%
contraction

Representative gross photographs are from 1-month implantation in NHP-AWR models from 4 different studies. These studies followed the same protocol and were performed at the same institution at different times. All materials were fixated to the edges of a 3 x 7 cm full-thickness defect in the abdominal wall of nonhuman primates in an interpositional bridging configuration.

As a synthetic mesh resorbs, it is replaced with scar tissue, which may impact the structure, function, and physiology of the repair site. An intact, extracellular matrix will enable the site to transition into host tissue with native structure, function, and physiology through regeneration.1,2

LEARN MORE about AlloDermTM RTM, an intact extracellular matrix that supports regeneration.†

†Correlation of these results, based on animal studies, to results in humans has not been established.
References: 1. Harper JR, McQuillan DJ. Extracellular wound matrices: a novel regenerative tissue matrix (RTM) technology for connective tissue reconstruction. Wounds. 2007;19(6):163-168. 2. Xu H, Wan H, Sandor M, et al. Host response to human acellular dermal matrix transplantation in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2009-2019. 3. Sandor M, Xu H, Connor J, et al. Host response to implanted porcine-derived biologic materials in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2021-2031. 4. Sandor M, Scott N, Edwards M, Qi S, De Deyne PG. In vitro and in vivo characterization of a fully resorbable and composite surgical mesh. J Bioactive Compat Polymers. 2014:1-16. doi:10.1177/0883911513520382 5. Data on file, Allergan; Study Report LRD2011-05-018. 6. Data on file, Allergan; Study Report LRD2014-10-011. 7. Data on file, Allergan; Study Report LRD2013-10-018. 8. Hollinsky C, Sandberg S. Measurement of the tensile strength of the ventral abdominal wall in comparison with scar tissue. Clin Biomech (Bristol, Avon). 2007;22(1):88-92. 9. Data on file, Allergan; Study Report LRD2010-05-002.
ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX INDICATIONS AND IMPORTANT SAFETY INFORMATION  

ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. ALLODERM SELECTTM RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK”. DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

Potential adverse events which may result from surgical procedures associated with the implant of a tissue graft include, but are not limited to, the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM.

To report an adverse reaction, please call Allergan Aesthetics at 1.800.433.8871.

ALLODERM SELECTTM Regenerative Tissue Matrix Indications and  Important Safety Information 

ALLODERM SELECTTM Regenerative Tissue Matrix
Indications and Important Safety Information

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. ALLODERM SELECTTM RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK”. DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

Potential adverse events which may result from surgical procedures associated with the implant of a tissue graft include, but are not limited to, the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM.

To report an adverse reaction, please call Allergan Aesthetics at 1.800.433.8871.